Improving Parental Psychosocial Functioning and Early Developmental Outcomes in Children With Sickle Cell Disease

NCT02394899 | Completed

• 1 other identifier: 0001
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

There are all significant risk factors for poor early cognitive development and, as such, neurocognitive deficits have been demonstrated in pre-school children with sickle cell disease (SCD). This project assesses the efficacy of using an evidence-based early stimulation program, combined with components to help parents cope with stress, delivered during six routine monthly clinic visits to parents of children with sickle cell disease. It is hoped that this innovation will improve parental psychological outcomes, as well as child developmental outcomes.

Conditions

Sickle Cell Disease; Cognitive Ability, General; Psychological Stress; Parenting

Keywords

SCD; early childhood intervention; parental stress; neurocognition

Outcome Measures

Primary Outcomes (3)

• Infant's development quotient (Griffiths Developmental Scale)

  Griffiths Developmental Scale

  6 months

• Parental stress, depression and coping (Pediatric Inventory for Parents; CES-D; Coping Health Inventory for parents)

  Questionnaires to assess: Pediatric Inventory for Parents; CES-D; Coping Health Inventory for parents

  6 months

• Parental problem solving skills (Social Problem Solving Inventory)

  Using Social Problem Solving Inventory: Questionnaires

  6 months

Study Arms (2)

Control

NO INTERVENTION

The control dyad will receive usual care.

Intervened

EXPERIMENTAL

Parents receive training in problem solving skills and play therapy with their infants.

Behavioral: Play therapy; Other: Problem solving skills

Interventions

Play therapy BEHAVIORAL

Short films that have been developed to deliver a series of child development messages will be shown at the monthly visits. Nine modules of approximate length 3 minutes each have been developed and cover the topics: Love, Comforting baby, Talking to babies and children, Praise, Using bath time to play and learn, Looking at books, Simple toys mothers can make, Drawing and games, and Puzzles. Nurses at the Sickle cell Unit (SCU) will be trained to discuss the video messages with the mothers/caregivers, demonstrate activities they can do with their children and how to make simple toys from household materials. Mothers/caregivers will practice some of the activities and they will be encouraged to make them part of their daily routine.

Intervened

Problem solving skills OTHER

Problem solving therapy (PST) aims to empower patients or caregivers in attending to daily challenges. It is based on cognitive behavioural therapy and can be used in primary care settings. It encourages persons to use existing resources and skills to function better and find solutions to problems. It will be delivered in 6 sessions over the 6-week period and will last for about 30 minutes per session. The stages of PST are: identification of the problems; generating possible solutions; evaluating and implementing preferred solution; and evaluating to see if the solutions were successful. The parent/caregiver will be taught a process of problem solving with reference to general everyday problems as well as specific problems which may arise while parenting a child with SCD.

Intervened

Eligibility Criteria

• Age: 6 Months - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infant has sickle cell disease: SS or Sβ0 thalassemia
• Attending Sickle Cell Unit, Jamaica for routine care

You may not qualify if:

• None

Sponsors & Collaborators

• The University of The West Indies: lead
• Grand Challenges Canada: collaborator

Study Sites (1)

Sickle Cell Unit, University of West Indies, Mona Campus

Kingston, Jamaica

Location

MeSH Terms

Conditions

Anemia, Sickle Cell; Stress, Psychological

Interventions

Play Therapy

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Jennifer Knight-Madden, MBBS, PhD

  The University of The West Indies

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2015
• First Posted: March 20, 2015
• Study Start: October 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: October 27, 2016

Record last verified: 2016-10

Locations

JA (1)